A second look at 510(k) changes

Compliance4All announces webinar on the topic, “A second look at 510(k) changes” on October 15. This webinar will help participants understand better ways by which to change a product that has already been cleared under 510(k).

Fremont, CA: Compliance4All, a provider of cost-effective regulatory compliance trainings for a wide range of regulated industries, will organize a webinar on the topic, “A second look at 510(k) changes” on October 15. Anna Longwell, principal attorney of the law firm, Longwell and Associates, will be the Speaker at this session.

About the webinar:

510 (k) changes is a topic that is still producing more than its share of 483’s and Warning Letters from the FDA. In general, FDA does not return filings because the change described in them is not sufficiently “significant”, and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).

For more information or to register for the webinar, please click here.

Therefore, it is up to the sponsor or manufacturer to determine whether this change will be significant or not. The decision has to be made by the manufacturer, subject to review by the FDA inspector. This webinar will provide quality and regulatory professionals the means to help the company make the right decision and document it fully, before the change goes through.

Even though generally the FDA will not insist on recalling a product with the change already in the market unless they decide there is a safety issue; this means disruption of the manufacturing (already producing the changed product) and marketing for the product. The best approach is to understand what FDA means by a “significant change” and document completely the reasons why the manufacturer or sponsor believes the change does not warrant a filing.

This webinar will help participants come out with ways by which to do this.

About the Speaker:

Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics.

Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled “Due Diligence Points to Consider” in the “Expert’s Guide to Healthcare Product Due Diligence” published by FDLI.

About Compliance4All:

Compliance4All (http://www.Compliance4All.com/) is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. Compliance4All offers a broad range of high quality, affordable regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.

Many professionals in the various areas in which Compliance4All offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.

Contact information:

Call: 1-800-447-9407;

Visit: http://www.netzealous.com/